Fitusiran Injection, Solution
NDC Package 12854-310-01

View Billable Units, 11-Digit Conversion Format, and RxNorm mappings
Table of Contents
    1. Package Information
    2. Frequently Asked Questions

Package Information

This product is an UNFINISHED DRUG part of the official NDC directory. Unfinished drugs include products like active ingredients some of which are used in bulk for further processing or compounding. The FDA requires a list of these drugs manufactured in a U.S. commercial distribution facility.

Fitusiran injection is a drug for further processing. This formulation utilizes a injection, solution delivery system. Marketed by Sanofi-aventis Deutschland Gmbh, this product is identified by NDC 12854-310.

Identification & Billing

NDC Package Code
12854-310-01
Package Description
21 CARTON in 1 BOX / 3 SYRINGE in 1 CARTON / .5 mL in 1 SYRINGE
Product Code
12854-310
11-Digit Billing Format
12854031001

Clinical Specifications

Proprietary Name
Fitusiran
Non-Proprietary Name
Fitusiran
Substance Name
Fitusiran
Dosage Form
Injection, Solution - A liquid preparation containing one or more drug substances dissolved in a suitable solvent or mixture of mutually miscible solvents that is suitable for injection.
Active Ingredient(s)
FITUSIRAN 50 mg/.5mL

Regulatory & Marketing

Labeler Name
Sanofi-aventis Deutschland Gmbh
Product Type
Drug For Further Processing
Marketing Category
DRUG FOR FURTHER PROCESSING - A drug (other than the bulk ingredient API) that is in an interim stage of manufacture, processing, preparation, or packaging, and not ready for human or animal use.
Start Marketing Date
03-28-2025
Listing Expiration
12-31-2026
Exclude Flag
N
Unfinished Product
Yes
Sample Package
N/A

Hierarchy Structure

Code Lineage

The NDC Directory contains ONLY information on final marketed drugs submitted to FDA electronically by labelers. A labeler might be a manufacturer, re-packager or re-labeler. The product information included in the NDC directory does not indicate that FDA has verified the information provided by the product labeler. Assigned NDC numbers are not in any way an indication of FDA approval of the product.

* Please review the full disclaimer at the bottom of this page.

Frequently Asked Questions

What is the distribution configuration for this product package?

The code 12854-310-01 identifies a specific commercial package of 21 carton in 1 box / 3 syringe in 1 carton / .5 ml in 1 syringe of Fitusiran (UNFINISHED drug), drug for further processing labeled by Sanofi-aventis Deutschland Gmbh. This injection, solution is formulated for use and contains fitusiran as the active substance.

Is this product currently listed with the FDA?

Yes, this product is active and verified within the NDC Directory. It was introduced to the market by Sanofi-aventis Deutschland Gmbh on March 28, 2025. The current certification is valid through December 31, 2026.

How is this Sanofi-aventis Deutschland Gmbh product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 12854031001. The table below illustrates the segment conversion from the 10-digit labeler code to the 11-digit provider format.

11-Digit Code Conversion

Billing payers usually require a 5-4-2 segment configuration. Below is the conversion from the 10-digit package format to the 11-digit billing format:

10-Digit Format (5-3-2)
12854-310-01
11-Digit CMS (5-4-2)
12854-0310-01

Note: The zero is added to the Product segment to maintain the 5-4-2 structure.